REMS Audit Oversight Lead

At GSK we have bold ambitions for patients aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform peoples lives. GSK fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success. Were uniting science technology and talent to get ahead of disease together.

This is a hybrid role based around the area of Philadelphia or New Jersey. Some travel may be required.

Find out more:
Our approach to R&D

You will lead oversight of Risk Evaluation and Mitigation Strategy (REMS) audit activities across the United States. You will design and manage REMS compliance audit programs partner with cross-functional teams and ensure compliance with regulatory requirements. We value clear thinking collaboration and a focus on continuous improvement. This role offers growth through high-impact work that helps protect patients and supports GSKs mission of uniting science technology and talent to get ahead of disease together.

This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following:
- Develop and manage a risk-based REMS audit compliance program for products and third-party partners.
- Plan and oversee execution of compliance audits by a third party to assess compliance with REMS requirements regulations and internal standards.
- Central point to trend audit findings and work with stakeholders to define and track corrective and preventative actions (CAPA).
- Serve as the subject matter expert during regulatory inspections and support inspection readiness activities.
- Create metrics and trend reports to identify systemic risks and recommend process improvements.
- Coach and mentor colleagues on audit methodology REMS compliance and quality expectations.

Collaboration and impact
You will work closely with regulatory affairs medical affairs safety commercial legal and external partners. You will translate regulatory expectations into practical audit plans. You will influence change by presenting clear evidence-based recommendations. You will help shape practices that protect patients and support timely access to medicines.

Why You
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

-Must reside within territory for consideration with access to a major airport.
- Bachelors degree in life sciences healthcare quality or related field.
- Minimum of 5 years experience in quality assurance regulatory compliance or audit within the pharmaceutical or healthcare industry.
- Direct experience with REMS programs including Experience planning and overseeing REMS audits and managing CAPA follow-up.
- Experience with U.S. regulatory requirements for risk management and pharmacovigilance.

Preferred Qualification
If you have the following characteristics it would be a plus:

- Advanced degree in life sciences pharmacy public health or related field.

-Strong written and verbal communication skills with experience presenting audit findings to stakeholders.
- Knowledge of pharmacovigilance systems and safety reporting requirements.
- Experience working with cross-functional global teams and third-party vendors and regulatory bodies.

-Experience with vendor oversight.

- Proficiency with data analytics or quality metrics.

- Experience operating in environments requiring rapid operational escalation and high-volume audit activities.

Working model and travel
- This role is hybrid with regular time in the office and the flexibility to work remotely as agreed with your manager.
- Some domestic travel (up to 10%) may be required for stakeholder meetings.

#LI-Remote

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK

Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

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